A far cry

After a long wait, the Indian Pharmacopoeia Comm-ission went operational recently. When the notification came on March 22, 2005, it was clear that the proposed structure neither provided for autonomy nor it had the expertise on board. The general body that constituted the society and the governing body that commanded the Commission, both were packed with bureaucrats. As earlier proposed by the IP Committee members and different stakeholders, the Commission has a three-tier structure like a society registered under the Societies Registration Act (General Body), a governing body and the scientific body. The governing body and general body are dominated by bureaucrats drawn from different ministries/departments such as health, finance, and other government institutions. The governing body is headed by the secretary, Ministry of Health & Family Welfare, whereas the notification states that the chairman will be a person of eminence with academic distinction in teaching and/or research in pharmaceutical and allied sciences or quality assurance of drugs or with experience in regulatory affairs relating to drugs. Not only that the entire exercise of IP Commission formation has gone futile but also the notification itself is making a mockery of things. The governing body was originally proposed to include around 8-10 members consisting of independent experts and three government representatives. Though after the notification, the stakeholders did seek changes in the structure of the commission so as to ensure efficient working of the organisation, the health secretary expressed his inability to make any major changes and tempted key stakeholders with a bone. The secretary offered to make the head of the Scientific Committee as co-chairman of the governing body. Dr Nityanand, the chairman of the Scientific Body and ex-chairman the IP Committee appears to be blissful with the arrangement.

However, this will mean a terrible blow to the drugs and pharmaceutical segment and the acceptance of Indian reference standards internationally. Not only that autonomy is hampered, a world-class IP Commission would always remain a dream. Apart from updating and upgrading Indian Pharmacopoeia regularly on similar lines as that of USP or BP, the IP Commission has the potential to develop and export world class reference standards. But this requires autonomy and expertise on board.

The Indian pharmaceutical industry is emerging as a key player in the global market. In this context, the Indian pharmacopoeial specifications need to be continuously updated so as to maintain the confidence in Indian drugs in the international market. This calls for a highly competent body with technical expertise and infrastructure support to develop and publish reference standards. The government should take immediate corrective measures to constitute the IP Commission akin to its international counterparts. The Commission’s head should be designated as secretary-cum-scientific director on the lines of British Pharmacopoeia Commission with full administrative and financial powers to manage the Commission. In place of only four editions in a span of last 50 years, the Indian Pharmacopoeia should come out with a new edition every year and should publish addenda at least twice a year. The IP Commission should be strengthened to help it regularly update the specifications so as to enable the pharmaceutical manufacturers to make available drugs of international standards.

—jaymenon2002@gmail.com